The Effect of Platelet Rich Plasma on Non-scarring Alopecia
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Dermatology, Dermatology, Hair Loss |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 1/6/2019 |
| Start Date: | October 1, 2018 |
| End Date: | October 2019 |
The purpose of this study is to evaluate the clinical efficacy of platelet rich plasma (PRP)
injections for non-scaring alopecia in women. A randomized, placebo-controlled clinical trial
will be performed where patients with non-scarring alopecia will either receive injections of
their own PRP or injections of normal saline (placebo). Patients in the treatment group
(Group A) will have a small amount of their own blood drawn and have their PRP injected into
their scalp four times. The injections will be given at weeks zero, four, eight, and twenty
four. The placebo group (Group B) will be given the same schedule but will receive sham
injections only and will not have any blood drawn. Both groups will have clinical data
collected at all visits, including a screening visit before enrollment and a final assessment
visit at week 40, for a total of 6 study visits per patient. Data collection will include
representative photographs of the scalp and measurements of hair thickness. The results from
the two groups will then be compared.
In summary, all study participants will have a screening visit before enrollment, four study
visits for sub-dermal scalp injections, and one final assessment visit at week 40.
injections for non-scaring alopecia in women. A randomized, placebo-controlled clinical trial
will be performed where patients with non-scarring alopecia will either receive injections of
their own PRP or injections of normal saline (placebo). Patients in the treatment group
(Group A) will have a small amount of their own blood drawn and have their PRP injected into
their scalp four times. The injections will be given at weeks zero, four, eight, and twenty
four. The placebo group (Group B) will be given the same schedule but will receive sham
injections only and will not have any blood drawn. Both groups will have clinical data
collected at all visits, including a screening visit before enrollment and a final assessment
visit at week 40, for a total of 6 study visits per patient. Data collection will include
representative photographs of the scalp and measurements of hair thickness. The results from
the two groups will then be compared.
In summary, all study participants will have a screening visit before enrollment, four study
visits for sub-dermal scalp injections, and one final assessment visit at week 40.
Inclusion Criteria:
1. Must understand and voluntarily sign an informed consent form
2. Must be female between the ages of 18 and 65 years at the time of consent
3. Must be able to adhere to the study visit schedule and other protocol requirements
4. Documented platelet count above 150,000 platelets per microliter within 6 months prior
to enrollment
Exclusion Criteria:
1. Previous or current use in the last 1 year of finasteride, minoxidil topical or oral,
or spironolactone
2. A diagnosis of non-androgenic alopecia (i.e: another diagnosis for the alopecia )
3. No Baseline ferritin, thyroid-stimulating hormone, platelet count, and a negative
urine pregnancy test in any pre-menopausal female in past 12 months.
4. Active skin disease (Psoriasis or severe seborrheic dermatitis) of the scalp
5. Scalp infection
6. Severe active blood infection
7. Cuts or abrasions on the scalp
8. History of surgical hair restoration
9. Current or recent malignancy
10. History of systemic chemotherapy or radiation
11. History of thyroid dysfunction
12. History of autoimmune disorder (specifically Graves disease, hashimoto thyroiditis, or
systemic lupus erythematosus)
13. Tendency to develop keloids
14. Nonsteroidal anti-inflammatory or Vitamin E discontinued in the last 7-14 days
15. Platelet dysfunction syndrome
16. Thrombocytopenia less than 150,000
17. Diagnosis of hypofibrinogenemia
18. Anticipated pregnancy or trying to become pregnant in the next 2 years
We found this trial at
1
site
1428 Madison Ave
New York, New York 10029
New York, New York 10029
(212) 241-6500
Principal Investigator: Hooman Khorasani, MD
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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